Kornimate/medical-research-clean huggingface dataset:
safety and antidepressant effects of rellidep in major depressive disorder

Conditions: Depression

Summary: the investigators hypothesize that rellidep will be effective in improving the symptoms of major depression. the available evidence strongly suggests that rellidep contains a mood altering ingredient or ingredients. this open-label, non-randomized study sets out to validate its potential antidepressant activity.the study will include secondary aims of evaluating the effect of rellidep on reducing symptoms of anxiety, a common symptom associated symptom of depression and improving quality of life. about twenty-five patients with major depressive disorder will be assigned to open-label rellidep (2000 mg/day) for a period of 8 weeks. all patients will be assessed by various measures of global improvement, depression, quality of life, sexual experience, anxiety and measures of side effects as well as standard laboratory tests.


Eligibility criteria:
inclusion criteria: * signed written informed consent obtained. * males/females 20-65 years of age who require a new or a new change in their medication treatment for diagnosed major depression. * a clinical diagnosis fulfilling dsm-ivtr criteria for major depressive disorder, single episode or recurrent. * 17-item hamilton depression rating scale (hamd 17-item) total score at baseline of 18 or higher exclusion criteria: * clinical diagnosis of depression other than dsm-ivtr major depressive disorder (single episode/recurrent, e.g. chronic depression and/or refractory depression are excluded). * judged to be at significant risk for suicide or having a history suggesting significant current potential for self harm. * antidepressant medication (other than the index antidepressant). * women who are pregnant or breast-feeding or intending to become pregnant in the next 12 months. * clinically significant organ system diseases, e.g. cardiovascular, hepatic, renal, endocrine, gastrointestinal, metabolic, or other systemic diseases. * course of electroconvulsive therapy (ect) during the observational period. * suffer from a major neurological condition (i.e., parkinson's disease, huntington's disease), cerebrovascular disease (i.e., stroke), metabolic conditions (i.e., vitamin b12 deficiency), autoimmune conditions (i.e., systematic lupus erythematosus), viral or other infections (i.e., hepatitis, mononucleosis, human immunodeficiency), and cancer. * current diagnosis of schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorders, psychotic disorder due to general medical condition, substance induced psychotic, psychotic disorder not otherwise specified) as defined in the dsm-iv. * (sub) clinical hypo/hyper thyroidism (e.g. elevated tsh).

Keywords: major depression antidepressant quality of life anxiety
nautilus: dynamic craniotomy; new surgical technique and preliminary results

Conditions: Children With Craniosynostoses

Summary: being the craniostenoses sutural basically a disease, the fact that the brain being trapped in an enclosure that does not have complacency required to accompany their growth constitutes the challenge of treatment, which aims to restore the complacency of the suture and correct the stenotic compensatory cranial deformity. this paper proposes the combination of a helicoid osteotomy distraction osteogenesis provided by the use of springs distracting.

as demonstrated by some authors, the curved shape of the helix fits perfectly the remodeling of a curved surface as well as the skullcap. if you do not receive fixation, however, trace the helicoid of the bone osteotomy can turn on a spring that can expand or contract depending on the direction of the force that is received. this form of osteotomy was therefore chosen by the authors to induce bone compliance areas of secondary defect that should expand or compress indirectly during the process of dynamic remodeling of primary defect with springs.

Eligibility criteria:
inclusion criteria: * age between 6 months to 13 years exclusion criteria: * absence of clinical conditions for the surgical treatment

Keywords: craniosynostoses osteogenesis distraction craniotomy
resp medication with a single intravenous administration and dose escalation to explore the tolerability ,safety and pharmacokinetic characteristics

Conditions: Chronic Renal Failure

Summary: the study is a single center and open test, and the dose of successive incremental method was taken. in order to determine the tolerance and safety after a single intravenous injection of different doses of resp in healthy subjects, the investigators had this trial. on the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.

the study is a single center and open test, and the dose of successive incremental method was taken. the study included 4 groups that is 0.5 ug/kg, 1.0ug/kg, 2.0ug/kg and 3.0ug/kg,the pharmacokinetic data (the screening period, before administration, after administration of 15, 30, 60 minutes, fourth, 8, 12, 24, 36, 48, 72 hours, seventh, 10, 14, 21, 28 days, 10 cases in each group) were collected. in order to determine the tolerance and safety after a single intravenous injection of different doses of resp in healthy subjects, the investigators had this trial. on the other hand, this study is to preliminarily explore the pharmacokinetics in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. aged 18-40 years old, male or female 2. subjects are previously healthy, and whose physical examinations are normal 14 days ago before the screening examination 3. the bmi is 19-25kg/m2 (bmi = weight / height2) 4. without anemia, white blood cell and platelet counts are normal 5. heart, lung, liver and kidney function are normal 6. without smoke and wine hobby 7. subjects voluntarily signing written informed consent. exclusion criteria: 1. allergic constitution or previous history of allergy of biological products; 2. pregnant and lactating women; 3. female subjects only take oral contraceptive pills and plan pregnancy during the clinical trials or within 3 months after administration; male subjects whose female partners plan pregnancy during the clinical trials or within 3 months after administration; 4. female subjects received postmenopausal estrogen therapy; 5. with malignant hypertension or hypertension is poorly controlled or with previous history of thromboembolic diseases and diseases of hematopoietic system 6. abnormal liver function ( ast or alt is 2 times greater than the upper limit of the normal) 7. hemoglobin is greater than or equal to 160g/l (male), 150 g/l (female) 8. the percentage of reticulocytes is greater than or equal to 3% 9. serum iron protein \<20ng/ml 10. subjects who donated blood 90 days before being enrolled or received a blood transfusion therapy or participate in other drug test 11. subjects who received recombinant erythropoiesis stimulating protein or rhuepo 3 months before being enrolled; 12. recombinant erythropoiesis stimulating protein antibody (resp) or endogenous erythropoietin (epo) antibody positive; 13. drugs known to have damage to some organs were given 3 months before being enrolled; 14. subjects whose hbsag, hbeag, anti-hiv, anti-hcv and syphilis antibody are positive; 15. researchers believe that other factors are not suitable for the trial
entecavir and tenofovir versus entecavir in lymphoma patients with positive hbv dna

Conditions: B-cell Lymphoma; HBV

Summary: this is a prospective, single-center, open-label, randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of hbv dna positive b-cell lymphoma patients. this study plans to enroll about 120 participants in total. recruitment will last for 2 years. the study visit will take place on the first day of each cycle of therapy until the end of the treatment. participants who meet the inclusion/exclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent. hbv dna will be measured before each cycle of chemotherapy or immunotherapy. when the copy count of hbv dna drops below 1\*10\^3/l, entecavir single agent will be given orally, until one year after the cycle of therapy. treatment response will be evaluated routinely after chemotherapy or immunotherapy. within 2 years after the last participant is enrolled, participants' survival information will collected by telephone and/or clinical visit every 3 months after the last visit (i.e. date and cause of death, subsequent cancer treatment, etc.), if there is no withdrawal of the informed consent form.


Eligibility criteria:
inclusion criteria: * treatment-naive, pathologically confirmed diagnosis of b-cell lymphomas with the viral load of hbv dna\>1\*10\^3/l * age≥18 years old * measurable lesions in radiographic images, defined as at least one well-defined lesions/knots, with both the long diameter and the short diameter≥1.5cm * life expectancy of at least 3 months according to researchers' judgement * written informed consent must be provided by participants or their legal representatives prior to any research examination or procedure exclusion criteria: * creatine\<50ml/min * any medical condition that may affect the conduction of this study according to researchers' judgement
effect of plant based high energy high protein oral nutritional supplement on nutritional intake in patients with or at risk of disease related malnutrition.

Conditions: Disease Related Malnutrition

Summary: the subjects will use study product twice daily for 8 weeks starting at visit 1. the recommendation is to consume one serving in the morning and one in the afternoon / evening between meals. the duration of the study for each subject will be approximately 11 weeks, comprising a screening period of max 2 weeks, an intervention period of 8 weeks, and a follow up phone call 1 week after completion of the intervention. a blood sample will be drawn at visit 1 and visit 3.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. identified as at medium or high risk of malnutrition based on: 1. must score ≥ 1 and / or 2. being prescribed with ons and willing and able to switch from pre-study prescribed ons to the test or control product for participation in the study 3. in need of 2 servings of ons/day (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional. 4. medically and physically able to consume high energy high protein ons in the opinion of the investigator. 5. willing to maintain dietary habits for the duration of the study. 6. willing to consume plant based as well as dairy based ons exclusion criteria: 1. known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (pib) and the appendix of this protocol). 2. known intolerance to any ingredients as listed in the study product composition (refer to pib and appendix of this protocol). subjects with lactose intolerance who use lactase may still be enrolled in the study. 3. any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis. 4. active flare of inflammatory bowel disease as defined by harvey-bradshaw index (hbi) \>6 (crohn's disease) or simple clinical colitis activity index (sccai) \>5 (ulcerative colitis). 5. requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by glomerular filtration rate \<30 ml/min/1.73 m2). 6. requiring enteral nutrition (via tube delivery) or parenteral nutrition. 7. subjects following a vegan diet.
natural orifice specimen extraction in sigmoid volvulus

Conditions: Mortality; Morbidity

Summary: sigmoid resection can be performed using conventional and laparoscopic methods. there are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.

sigmoid resection can be performed using conventional and laparoscopic methods. there are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus. the documents of patients who were operated on for sigmoid volvulus between 2018 and 2019 were retrospectively reviewed. patients who had been used transanal for specimen extraction by elective laparoscopic sigmoid colon resection were included in the study. patients' gender, age, comorbidity, operation time, operative difficulties, complications, length of stay, and mortality findings were analyzed. laparoscopic sigmoid resection and transanal specimen removal were performed in eight patients. specimen extraction surgery from the natural hole is increasingly preferred. the investigators think that natural hole surgery can be performed more easily and reliably in sigmoid volvulus due to the large diameter of the colon.

Eligibility criteria:
inclusion criteria: * transanal for specimen extraction by elective laparoscopic sigmoid colon resection exclusion criteria: * emergency surgery * conventional open sigmoid resection * conventional laparoscopic sigmoid resection

Keywords: colon volvulus natural orifice laparoscopy sigmoid
the combined usage of clinical physical finding in management of covid 19 patients

Conditions: COVID-19 Pandemic

Summary: physiological indicators such as blood pressure, heart rate, respiratory rate, and consciousness status of covid-19 patients are used to apply the start (simple triage and rapid treatment, start), modified early warning score (mews), and quick sequential organ failure assessment (qsofa) as tools for assessing clinical symptom tracking, deterioration, and subsequent improvement in covid-19 patients. in response to the need for scarce manpower when a large number of emergency patients appear, a simple and easy-to-operate assessment method is adopted for mild patients, and artificial intelligence technology can be further used to assist in the assessment for early response and medication.

due to the development of the pandemic , the virus has constantly mutated, leading to a vast majority of mild cases. this has significantly increased the burden on medical personnel. the investigators are trying to find a way to track whether their clinical symptoms have worsened. at the same time, the investigators want to know the changes in patient symptoms in real-time through online monitoring this is a single-center retrospective study of a group of covid-19 patients. review their medical records, mainly based on hospital field records and existing physiological indicators of patients such as blood pressure, heart rate, respiratory rate, and consciousness status. the partients visited the hospital between march 2020 and september 2022. all patients were given physiological value indicators mews, qsofa, and start for scoring and assess the clinical symptom deterioration of covid-19 patients. in this study, the investigators collect the physiological values of each patient and the data on the nursing records during hospitalization to judge whether the symptoms have worsened

Eligibility criteria:
inclusion criteria: * a group of hospitalized covid 19 patients were treated in the hospital between march 2020 and sep.2022 exclusion criteria: exclude patients who lack information in their medical records and incomplete clinical data. -

Keywords: blood pressure heart rate respiratory rate consciousness status quick sequential organ failure assessment (qsofa)
a safety and tolerability study of regn88(sar153191) in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (sc) administered regn88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed sc.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age 2. subjects must weigh \>50 and \<100 kg 3. diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised american college of rheumatology (acr) criteria with disease duration of no less than 6 months and acr class i-iii exclusion criteria: 1. a history of listeriosis or active tuberculosis (tb) 2. persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit 3. history of prior articular or prosthetic joint infection 4. history of a hypersensitivity reaction, other than localized injection site reaction (isr), to any biological molecule 5. significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
the role of endogenous glucagon-like peptide 1 (glp-1) in type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to determine the contribution of endogenous glucagon-like peptide 1 (glp-1) to the postprandial secretion of insulin and glucagon and the incretin effect in healthy subjects and patients with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (t2dm) * must be able to complete a 1 week wash-out of current anti-diabetic medications * age 30-70 years * hba1c (hemoglobin a1c) ≤11% at screening * body mass index (bmi) \<40 kg/m2 * patients with type 2 diabetes mellitus (t2dm): must have a fasting blood glucose of ≤12.2 mmol/l (240 mg/dl) at screening * able to provide written informed consent prior to study participation * able to communicate well with the investigator and comply with the requirements of the study exclusion criteria: * patients with type 1 diabetes mellitus (t1dm), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg cushing, acromegaly) * need for insulin within the previous 3 months * use of thiazolidinediones in the previous 4 weeks * significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis). * treatment with systemic steroids and thyroid hormone (unstable dosage). * patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc. * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. * donation or loss of 400 ml or more of blood within 8 weeks prior to dosing. * significant illness within the two weeks prior to dosing. * past medical history of clinically significant ecg abnormalities or a family history of a prolonged qt-interval syndrome. * history of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). a known hypersensitivity to the study drug or drugs similar to the study drug. * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; * history or clinical evidence of pancreatic injury or pancreatitis; * history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria); * evidence of urinary obstruction or difficulty in voiding at screening; * polymorphonuclears \<1500/µl at inclusion or platelet count \< 100,000/μl at screening and baseline. * history of immunocompromise. * evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/l (1.6 mg/dl).

Keywords: glp-1 exendin(9-39) insulin glucagon t2dm incretin effect human physiology
a study on the pathogenesis and determinants of intravenous leiomyomatosis

Conditions: Intravenous Leiomyomatosis; HPV Infection

Summary: the goal of this observational study is to learn about the impact of hpv infection in women with intravenous leiomyomatosis(ivl). the main question it aims to answer is: does hpv infection promote the development of ivl from uterine leiomyoma? surgical sections and hpv-dna test results will be collected in participants diagnosed with ivl or uterine leiomyoma.

previous proteomic studies have demonstrated that hpv infection-related proteins are more highly expressed in intravenous leiomyomatosis (ivl) compared to uterine leiomyoma (uml). consequently, we conducted a case-control study to investigate the association between hpv and the development of ivl. we recruited adult patients diagnosed with either ivl or uml, collected their medical histories, surgical specimens from various sites, and hpv-dna test results from cervical exfoliated cells, and performed subsequent statistical analyses and mechanistic investigations.

Eligibility criteria:
inclusion criteria: * adult female patients with suspected ivl or uterine leiomyoma who receive surgery at pumch * be able to understand and sign the informed consent exclusion criteria: * patients with other concurrent malignant tumors * pregnant or lactating female * postoperative pathology do not include ivl or uterine leiomyoma

Keywords: intravenous leiomyomatosis hpv